FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

SpaceOAR System Acquires Shonin Approval in Japan

June 1, 2017
A A

Augmenix has received approval from the Japanese Ministry of Health, Labor and Welfare to market its SpaceOAR system in Japan.

SpaceOAR hydrogel is an absorbable prostate-rectum spacer that reduces rectal injury during prostate radiotherapy.

The hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer, to reduce the radiation dose delivered to the anterior rectum.

SpaceOAR is CE marked, FDA cleared, approved in Australia and licensed in Canada. — Cynthia Jessup

View today's stories